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Isolation and purification of impurity by preparative Chromatography (HPLC)

Impurities can arise at very low concentrations relative to the API during manufacturing process or a stability study for an Active Pharmaceutical Ingredient (API) or drug product, impurities might occur as degradation products, as intermediates/process impurities originating from the synthetic route, as an unwanted by-product of side-reactions or due to contamination of the original sample are isolated by preparative Chromatography (HPLC) at Allmpus.

Requirements:-

Analytical Requirements:-

  1. % or concentration of impurity relative to the API
  2. Analytical Method with representative chromatogram
  3. Preparative method if available

Sample requirements:-

  1. Depends on the impurity content
  2. For product-related impurities in the low percentage area, 200 mg sample are typically sufficient to obtain 1 mg of the enriched impurity